Irritable Bowel Syndrome - Ketotifen.

Completed

• Registration Number: NL-OMON23097

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

Fulfilling Rome II criteria of IBS, 18-65 years of age, no other organic abnormalities explaining the complaints.

Exclusion Criteria

Severe comorbidity, use of sedatives, hypnotics or antihistamines, pregnancy/lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of the mastcell-stabilizer ketotifen on the rectal sensitivity in IBS. <br /><br>Participants are treated with ketotifen twice daily 2-6 mg or placebo during eight weeks.<br /> <br>To assess the rectal sensitivity a barostat investigation is performed before and after the treatment-period.

Secondary Outcome Measures

Name	Time	Method
The effect of the mastcell-stabilizer ketotifen on inflammation in rectal biopsy specimen and the effect of ketotifen on IBS-symptoms.